Collaborative Care for Children's Mental Health Problems

NCT03144739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1111

Last updated 2019-10-17

No results posted yet for this study

Summary

Background: Mental health problems cause a disproportionate burden of disability among children and youth compared to adults. Primary care plays an important role in efforts to prevent and intervene early in the course of child and adolescent mental health problems. While research with adults has shown the feasibility of integrating mental health care into primary care settings, there have been few studies among children and youth. Evidence remains lacking that integration is feasible in diverse settings, that it improves outcomes, and that methods can be developed to address the mixed symptoms of emerging child/youth problems and their overlap with developmental and parental disorders.

Goals: The purpose of this project is to test the effectiveness of adding a child/youth mental health component into an existing collaborative care program for adult mental health problems. The work will refine a framework for efficient cultural adaption and tailoring of an existing child/youth primary care mental health intervention and then test whether the tailored intervention results in improved child and parent outcomes. The work will also provide evidence about the mechanisms by which those outcomes are achieved and what factors influence uptake of the child/youth component by general practitioners (GPs). These results should be generalizable to low and middle income countries and to underserved areas of the US where there are minimal child mental health resources and family physicians provide the bulk of medical care for children and youth.

Methods: The planned work involves the adaptation/tailoring process followed by a trial with 45 GPs already engaged in collaborative care for adults; the trial will study adding collaborative care for children ages 5-15. GPs will be randomly assigned in groups to begin 6-month control periods involving child mental health screening and referral. They will then receive child/youth training and begin second 6-month periods of screening plus ongoing coaching and booster sessions and collaborative management. Primary outcomes will be measured by recruiting and following for 6 months two cohorts of children/youth and their parents (one control, one collaborative care). Data collected from GPs, parents, youth, and the collaborative care data system will allow measurement of key factors that determine the program's success in helping children and families.

Conditions

  • Depression
  • Anxiety
  • Attention Deficit Hyperactivity Disorder
  • Oppositional Defiant Disorder
  • Parent-Child Relations
  • Substance Use

Interventions

OTHER

Training in management of children's mental health problems

General practitioners will be trained using internationally-developed materials, including the World Health Organization's "mental health need/service gap (mhGAP)" materials and others, adapted for the trial setting (based on formative work that is part of the project). They will be assisted and monitored as part of the ongoing collaborative care program in which they are participating.

OTHER

Current collaborative care protocol

General practitioners have been trained to recognize children's mental health problems and to refer them to a partner community mental health center. They receive feedback about the referral but are not encouraged to take on care for the child themselves.

Sponsors & Collaborators

Principal Investigators

  • Lawrence S Wissow, MD · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Iran

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144739 on ClinicalTrials.gov